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Government Health Agency News

FDA

Dovato's indications expanded to include adolescents living with HIV

April 16, 2024

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FDA expanded the indications for dolutegravir/lamivudine (Dovato) to include treatment of HIV-1 infection in adolescents ≥12 years of age and weighing ≥25 kg with no ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato. According to a manufacturer press release, Dovato is now the first and only oral, two-drug, single-tablet regimen available for people ≥12 years living with HIV.

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